(67 days)
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided document describes the acceptance criteria and study for the HEBEI LEADER PLASTIC CO., LTD's "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)." This is a medical device, and the evaluation focuses on its conformance to established standards for patient examination gloves.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner (as per Medical Glove Guidance Manual 1661) | Is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Device Description & Specifications | Meets ASTM D5250 (If vinyl: meet all current specifications listed under ASTM Specification D5250 or equivalent consensus standard) | Meets ASTM D5250 |
| Materials | PVC (If the glove is made of a polymer or other type of material, identify the material.) | PVC |
| Dusting or Donning Powder (Lubricant) | PU (If a donning lubricant is used, state the composition and include biocompatibility data for the lubricant in an identified attachment; also state the name, manufacturer, and address below) | PU (Surface Coating Agent) |
| Product Specifications | Meets ASTM D5250 standard or an equivalent standard for vinyl | Meets ASTM D5250 |
| Performance Data (Holes) | ASTM D5151 (Detection of Holes in Medical Gloves) | Meets ASTM D5151 |
| Performance Data (Residual Powder) | ASTM D6124 (Residual Powder on Medical Gloves) | Meets ASTM D6124 |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES (Meets ISO 10993-10) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 |
| Waterleak Test on Pinhole AQL | FDA requirements for waterleak test on pinhole AQL | Meets FDA requirements for waterleak test on pinhole AQL |
| General Requirements | Meets 21 CFR 800.20 | Meets 21 CFR 800.20 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., ASTM D5151, D6124, biocompatibility). However, it implies that the device "meets" these standards, which typically involve specific sampling plans and test methods outlined within the respective standard.
- Data Provenance: The manufacturing company is HEBEI LEADER PLASTIC CO., LTD, located in Shijiazhuang, China. The testing likely occurred in China, although the specific laboratories are not identified.
- Retrospective or Prospective: The testing appears to be prospective as it was conducted to demonstrate substantial equivalence for the premarket notification (510(k)) of a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable (N/A) for this device. The "ground truth" for medical gloves is established by adherence to recognized consensus standards (like ASTM and ISO) for physical properties and biocompatibility. It does not involve subjective human interpretation or diagnostic decision-making that would require expert consensus on a test set.
4. Adjudication Method for the Test Set
This is not applicable (N/A) for this device. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers evaluate data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth. For medical gloves, performance is measured against objective physical and chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (often AI-powered) where human performance can be augmented or improved by AI assistance. This device is a patient examination glove, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance assessment was not done. This concept is applicable to AI/ML algorithms. The device being reviewed is a physical medical glove.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on recognized consensus standards (ASTM D5250, ASTM D5151, ASTM D6124) and regulatory requirements (21 CFR 800.20, ISO 10993-10 for biocompatibility). These standards define objective pass/fail criteria for the physical and chemical properties of the gloves.
8. The Sample Size for the Training Set
This is not applicable (N/A). Training sets are used for machine learning algorithms. The evaluation of this medical glove relies on physical and chemical testing against established standards, not on training an AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (N/A) for the same reason as above. There is no AI training set involved.
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"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: در بہ (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | HEBEI LEADER PLASTIC CO., LTD | ||
|---|---|---|---|
| Submitter's address : | #77, ZHONGSHAN WEST RD.SHIJIAZHUANG,050000 CHINA | ||
| Phone number : | (86) 311-67699886 | ||
| Fax number : | (86) 311-67699916 | ||
| Name of contact person: | Mr. WANG Fei | ||
| Date the summary was prepared: | Sep. 19th, 2012 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder free Vinyl Patient Examination Gloves, Colored(Yellow) |
|---|---|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .
[(a)(4)] A description of the device
Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) is a. disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &Description | Predicate Device | Medical GloveGuidanceManual(1661) | Subject Device | Result ofComparison |
|---|---|---|---|---|
| Company | SHIJIAZHUANG MANFULLIGHTINDUSTRIALPRODUCTSCO., LTD | HEBEI LEADERPLASTIC CO.,LTD | -- | |
| Product name | Powder freeVinyl PatientExaminationGloves(White,Yellow) | Powder free VinylPatientExaminationGloves, Colored(Yellow) | -- | |
| Intend for use | Powder freeVinyl PatientExaminationGloves, Colored(White, Yellow)is a disposabledevice intendedfor medicalpurposes that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner. | Powder-FreeExaminationGloves:A powder-freepatient examinationglove is a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Powder free VinylPatientExaminationGloves, Colored(Yellow) is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTMD5250 | If vinyl:Do the vinylexamination glovesmeet all the currentspecifications listedunder ASTMSpecification D5250or an equivalentconsensus standard? | Meets ASTMD5250 | Substantiallyequivalent |
| Compare allmaterials used tofabricate thedevices | PVC | If the glove is madeof a polymer orother type ofmaterial. identify thematerial. | PVC | Substantiallyequivalent |
| Dusting orDonning Powder: | PU | If a donninglubricant is used | PU | Substantiallyequivalent |
| state the composition and include biocompatibility data for the lubricant in an identified attachment; also state the name, manufacturer, and address below | ||||
| Dusting orDonning Powder:name | PU | LubricantGeneric Name/LubricantBrand Name | Surface CoatingAgent | Substantiallyequivalent |
| Compare productspecifications | Meets ASTMD5250 | We recommend you certify that your finished "powder-free" gloves meet the following:ASTM D 5250 standard or an equivalent standard for vinyl | Meets ASTMD5250 | Substantiallyequivalent |
| Compareperformance datasupportingsubstantialequivalence | MeetsASTM D5151ASTM D5250ASTM D6124 | At this time FDA recognizes the following standards:Patient Examination Gloves(PVC)ASTM D5151(Detection of Holes in Medical Gloves)ASTM D6124(Residual Powder on Medical Gloves)ASTM D5250(Poly(vinyl chloride) Gloves) | MeetsASTM D5151ASTM D5250ASTM D6124 | Substantiallyequivalent |
| Single Patient Use | Single PatientUse | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | SKINIRRITATIONDERMAL andSENSITIZATIONSTUDIESMeets ISO10993-10 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESISO 10993-10 | SKINIRRITATIONDERMAL andSENSITIZATIONSTUDIES MeetsISO 10993-10 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder-Free-PatientExaminationGlove-Single Use Only- ManufacturedFor:- Lot | Chapter 4 | -Powder-Free-PatientExamination Glove-Single Use Only- ManufacturedFor:- Lot | Substantiallyequivalent |
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[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2006 Third Edition 2010-08-01.
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[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
[(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims .
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Section 15
Substantial Equivalence Discussion
The Powder free Vinyl Patient Examination Gloves, Colored (Yellow) made by HEBEI LEADER PLASTIC CO., LTD, have the same intended use and technological characteristics as the Predicate devices, Powder free Vinyl Patient Examination Gloves(White, Yellow) made by SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156.
The Subject Device is substantially equivalent to the predicate devices with regard to technologies, in design and very similar construction, material, function, and application. More detail information on the Table 1.
Based on the information in following Table I, II & III , the Subject Device (Powder free Vinyl Patient Examination Gloves, Colored (Yellow)) has the same technological characteristics as the predicate device. The Powder free Vinyl Patient Examination Gloves, Colored (Yellow) made by HEBEI LEADER PLASTIC CO., LTD, are substantially equivalent to the predicate devices.
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Image /page/5/Picture/0 description: The image shows a logo for the Department of Health and Human Services - USA. The logo includes a symbol with three curved lines, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol. The text is in a circular format.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 30, 2012
Hebei Leader Plastic Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, China 100083
Re: K122920
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 19, 2012 Received: November 1, 2012
Dear Mr. Xiaoan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Xiaoan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Heath's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Anthong Lo min
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: HEBEI LEADER PLASTIC CO., LTD
510(k) Number (if known): * 122920
Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)
Indications For Use:
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Maria Cruz-ISher Cruz-Fisher Scorminaria Cruzen. Maria Cruzen. Maria Cruzena. Maria 1920200.00.11.1.
Data 113112 - Data 113.000 1130113011301130113011131114910 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K122420
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.